Abbott Highlights New AVEIR™ Data, Initiates Trial for the Company's Conduction System Pacing Technology
Abbott (NYSE: ABT) announced breakthrough results from its AVEIR™ Conduction System Pacing (CSP) acute clinical feasibility study, the world's first assessment of a leadless pacemaker delivering conduction pacing to the heart's left bundle branch area. The study demonstrated successful implantation of the AVEIR CSP leadless pacemaker technology.
Additionally, Abbott has initiated the ASCEND CSP pivotal clinical trial to evaluate their investigational CSP Implantable Cardioverter-Defibrillator lead, which will enroll up to 414 people across 70 global sites. The company received FDA Breakthrough Device Designations for both the AVEIR CSP leadless pacemaker system and the CSP ICD lead for left bundle branch area pacing (LBBAP).
Abbott's UltiPace™ Pacing Lead became the first FDA-approved stylet-driven lead indicated for left bundle branch area placement, marking significant progress in their cardiac rhythm management portfolio.
Abbott (NYSE: ABT) ha annunciato risultati rivoluzionari dal suo studio clinico di fattibilità acuta sull’AVEIR™ Conduction System Pacing (CSP), la prima valutazione al mondo di un pacemaker senza elettrodo che fornisce stimolazione della conduzione nell'area del fascio di His sinistro. Lo studio ha dimostrato il successo nell’impianto della tecnologia pacemaker senza elettrodo AVEIR CSP.
Inoltre, Abbott ha avviato il trial clinico pivotale ASCEND CSP per valutare il loro elettrodo impiantabile CSP ICD sperimentale, che arruolerà fino a 414 persone in 70 centri a livello globale. L’azienda ha ottenuto la designazione Breakthrough Device dalla FDA sia per il sistema pacemaker senza elettrodo AVEIR CSP sia per l’elettrodo CSP ICD per la stimolazione dell’area del fascio di His sinistro (LBBAP).
Il sistema di elettrodi UltiPace™ di Abbott è diventato il primo elettrodo guidato da stiletto approvato dalla FDA indicato per il posizionamento nell’area del fascio di His sinistro, segnando un progresso significativo nel portafoglio di gestione del ritmo cardiaco dell’azienda.
Abbott (NYSE: ABT) anunció resultados innovadores de su estudio clínico de factibilidad aguda AVEIR™ Conduction System Pacing (CSP), la primera evaluación mundial de un marcapasos sin cable que proporciona estimulación de conducción en la zona del haz de His izquierdo. El estudio demostró la implantación exitosa de la tecnología de marcapasos sin cable AVEIR CSP.
Además, Abbott ha iniciado el ensayo clínico pivotal ASCEND CSP para evaluar su electrodo implantable CSP ICD en investigación, que inscribirá hasta 414 personas en 70 sitios globales. La compañía recibió la designación de Dispositivo Innovador (Breakthrough Device) de la FDA tanto para el sistema de marcapasos sin cable AVEIR CSP como para el electrodo CSP ICD para la estimulación en la zona del haz de His izquierdo (LBBAP).
El electrodo UltiPace™ de Abbott se convirtió en el primer electrodo guiado por estilete aprobado por la FDA indicado para la colocación en la zona del haz de His izquierdo, marcando un avance significativo en su portafolio de manejo del ritmo cardíaco.
애보트(Abbott, NYSE: ABT)는 AVEIR™ 전도계통 페이싱(CSP) 급성 임상 타당성 연구에서 획기적인 결과를 발표했습니다. 이 연구는 심장 좌측 속다발 부위에 전도 페이싱을 제공하는 무전극 심박조율기를 세계 최초로 평가한 것입니다. 연구 결과 AVEIR CSP 무전극 심박조율기 기술의 성공적인 이식이 입증되었습니다.
또한, 애보트는 최대 414명의 환자를 전 세계 70개 기관에서 모집하는 ASCEND CSP 중추 임상시험을 시작했습니다. 이 시험은 연구 중인 CSP 이식형 제세동기(ICD) 전극을 평가하기 위한 것입니다. 회사는 AVEIR CSP 무전극 심박조율기 시스템과 좌측 속다발 부위 페이싱(LBBAP)을 위한 CSP ICD 전극 모두에 대해 FDA 혁신 의료기기 지정(Breakthrough Device Designations)을 받았습니다.
애보트의 UltiPace™ 페이싱 전극은 FDA 승인을 받은 최초의 스틸렛 구동 전극으로, 좌측 속다발 부위에 위치시키는 용도로 승인받아 심장 리듬 관리 포트폴리오에서 중요한 진전을 이루었습니다.
Abbott (NYSE : ABT) a annoncé des résultats révolutionnaires issus de son étude clinique de faisabilité aiguë AVEIR™ Conduction System Pacing (CSP), la première évaluation mondiale d’un stimulateur cardiaque sans fil délivrant une stimulation de conduction dans la zone du faisceau de His gauche. L’étude a démontré l’implantation réussie de la technologie de stimulateur sans fil AVEIR CSP.
De plus, Abbott a lancé l’essai clinique pivot ASCEND CSP afin d’évaluer leur électrode CSP défibrillateur cardioverteur implantable en phase d’investigation, qui recrutera jusqu’à 414 personnes dans 70 sites à travers le monde. La société a reçu la désignation de dispositif révolutionnaire (Breakthrough Device) par la FDA pour le système de stimulateur sans fil AVEIR CSP ainsi que pour l’électrode CSP ICD pour la stimulation de la zone du faisceau de His gauche (LBBAP).
Le système d’électrodes UltiPace™ d’Abbott est devenu la première électrode guidée par stylet approuvée par la FDA, indiquée pour le placement dans la zone du faisceau de His gauche, marquant une avancée significative dans leur portefeuille de gestion du rythme cardiaque.
Abbott (NYSE: ABT) gab bahnbrechende Ergebnisse seiner akuten klinischen Machbarkeitsstudie zum AVEIR™ Conduction System Pacing (CSP) bekannt, der weltweit ersten Bewertung eines kabellosen Herzschrittmachers, der eine Leitungsstimulation im Bereich des linken Tawara-Schenkels liefert. Die Studie zeigte eine erfolgreiche Implantation der kabellosen AVEIR CSP Herzschrittmacher-Technologie.
Zusätzlich hat Abbott die ASCEND CSP Schlüsselklink-Studie gestartet, um ihre experimentelle CSP Implantierbare Kardioverter-Defibrillator-Elektrode zu evaluieren, bei der bis zu 414 Personen an 70 globalen Standorten eingeschlossen werden. Das Unternehmen erhielt von der FDA die Breakthrough Device Designations sowohl für das kabellose AVEIR CSP Herzschrittmachersystem als auch für die CSP ICD-Elektrode für die Stimulation im Bereich des linken Tawara-Schenkels (LBBAP).
Die UltiPace™ Stimulations-Elektrode von Abbott wurde als erste von der FDA zugelassene, mit einem Führungsdraht betriebene Elektrode für die Platzierung im Bereich des linken Tawara-Schenkels zugelassen und markiert einen bedeutenden Fortschritt im Portfolio des Unternehmens für das Management des Herzrhythmus.
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Insights
Abbott advances cardiac rhythm management with breakthrough device designations and clinical progress for innovative conduction system pacing technologies.
Abbott's announcements represent significant momentum in their cardiac rhythm management portfolio. The successful completion of the world's first feasibility study for their AVEIR Conduction System Pacing (CSP) leadless pacemaker technology demonstrates a novel approach to cardiac pacing. The study verified successful implantation of leadless pacemakers into the interventricular septum, achieving left bundle branch area pacing that mimics natural heart conduction.
The FDA Breakthrough Device Designations for both the AVEIR CSP leadless pacemaker and CSP ICD lead are particularly significant, potentially accelerating regulatory review timelines. This could give Abbott a competitive advantage in bringing these technologies to market.
Strategically, Abbott is pursuing dual technological approaches in this space: both leadless technology and traditional lead-based systems. This two-pronged strategy expands their potential market reach while hedging technological risk.
The initiation of the ASCEND CSP pivotal clinical trial for their ICD lead represents critical progression toward commercialization. The trial will enroll up to 414 patients across 70 global sites to evaluate safety and effectiveness at three months post-implant. Abbott's UltiPace Pacing Lead has already received FDA approval as the first stylet-driven lead indicated for left bundle branch area placement, giving the company an established foundation in this emerging pacing approach.
Conduction system pacing technology could transform cardiac rhythm management by offering more physiologic pacing and potentially better long-term outcomes.
The clinical significance of Abbott's conduction system pacing innovations cannot be overstated. Traditional pacing methods often stimulate the heart from locations that create electrical activation patterns significantly different from normal conduction. This can lead to cardiac dyssynchrony and, over time, pacing-induced cardiomyopathy in some patients.
Left bundle branch area pacing (LBBAP) represents a paradigm shift by targeting the heart's natural conduction system. By delivering pacing therapy directly to the left bundle branch area, these devices aim to restore more natural electrical patterns, potentially reducing the risk of heart failure and improving cardiac function. The AVEIR CSP acute feasibility study demonstrated that a leadless pacemaker can successfully achieve this technically challenging placement.
The dual development approach - incorporating both the innovative leadless AVEIR system and the traditional lead-based ASCEND platform - gives clinicians multiple options to address patient-specific needs. Leadless systems eliminate complications associated with transvenous leads such as infection, vascular damage, and lead fractures, while the lead-based approach allows integration with existing ICD systems.
With Breakthrough Device Designations for both technologies, these innovations could reach patients more quickly. While early-stage results are promising, the upcoming pivotal trial data will be crucial in determining whether these technologies can deliver on their potential to transform cardiac pacing therapy with more physiologic stimulation patterns.
- Late-breaking data from Abbott's groundbreaking first-in-human study demonstrated successful implantation of the company's AVEIR Conduction System Pacing (CSP) leadless pacemaker
- Enrollment has also begun in the ASCEND CSP pivotal clinical trial to evaluate Abbott's investigational CSP Implantable Cardioverter-Defibrillator (ICD) lead
- Conduction System Pacing is an evolving technique specifically designed to deliver pacing to the left bundle branch area of the heart to restore its natural electrical rhythm
The results were presented as a late-breaking clinical trial at the Heart Rhythm Society's (HRS) 46th annual meeting in
The AVEIR CSP acute clinical feasibility study demonstrated successful implantation of the AVEIR CSP leadless pacemaker deep into the wall separating the left and right chambers of the heart, many achieving left bundle branch area pacing (LBBAP). All study participants received the AVEIR ventricular (VR) leadless pacemaker at the end of the procedure.
"For the first time, we have successfully demonstrated the feasibility of a leadless pacing system to facilitate conduction system pacing in the left bundle branch area of the heart, offering a novel approach to pacing therapy," said Vivek Y. Reddy, M.D., director of cardiac arrythmia services at Mount Sinai Hospital,
Conduction Pacing Momentum within Abbott's Cardiac Rhythm Management Portfolio
To maximize potential benefits to patients, Abbott is developing two unique approaches to conduction system pacing, focusing on targeting the LBB area with both traditional pacing and leadless technology.
In addition to completing the AVEIR CSP acute clinical feasibility study, Abbott recently started enrolling the first patients in the ASCEND CSP pivotal clinical trial. This trial will evaluate the safety and effectiveness of the investigational CSP Implantable Cardioverter-Defibrillator (ICD) lead three months post-implant and will enroll up to 414 people at up to 70 sites worldwide, including in
Abbott's UltiPace™ Pacing Lead is the first FDA-approved stylet-driven lead indicated for left bundle branch area placement. Recently, the
"Our ongoing innovation in conduction system pacing has the potential to drive meaningful advancements, offering new potential treatment options for people with slow or irregular heart rhythms," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business. "These two clinical studies underscore the critical importance of conduction system pacing in the left bundle branch area both with our breakthrough leadless technology and uniquely designed lead, enabling physicians to better treat a broader range of patients who require pacemaker and ICD therapies."
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.
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